NCT02603614

Safety Study of Cenderitide in Chronic Stable Heart Failure With Moderate Renal Impairment

A Randomized, Double Blind, Placebo-Controlled, Dose Escalating, Cross Over Designed Study to Assess the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Open-Label, Continuous Subcutaneous Infusion of Cenderitide Via the Insulet Drug Delivery System in Chronic Stable Heart Failure Subjects With Moderate Renal Impairment

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Capricor Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CNDP-578-02 is a randomized, double-blind, placebo-controlled, dose-escalation, crossover design trial. Eight evaluable subjects (n=8) with chronic stable heart failure and moderate renal impairment will be randomized (1:1) to receive cenderitide or placebo. Enrolled subjects will begin with Infusion Period A where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo via the Insulet Drug Delivery System. Enrolled subjects will then cross over into Infusion Period B where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo.

Conditions

• Heart Failure
• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Cenderitide	Cenderitide is a dual receptor natriuretic peptide.
DRUG	Placebo	Placebo control

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-03-31
• Completion: 2016-03-31
• First posted: 2015-11-13
• Last updated: 2020-02-11

Locations

1 site across 1 country: United States